Safety and Efficacy Study of Anti-PD1 Armored CD19 CAR-T Cells in Adult Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Sponsor
Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
Study ID
NCT07368270
Phase
PHASE1
Status
Recruiting
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Conditions

  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Anti-PD1 armored CD19 CAR-T cells — BIOLOGICAL
    Anti-PD1 armored CD19 CAR-T cells, single intravenous infusion

Study Details

The purpose of this study is to investigate the safety and tolerability of anti-PD1 armored CD19 CAR-T Cells in adult subjects with relapsed or refractory diffuse large B-cell lymphoma.

Key Dates

First listed
Jan 26, 2026
Start date
Jan 31, 2026
Status verified
Jan 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Anti-PD1 armored CD19 CAR-T cells treatment arm
    Subjects will be administrated with Anti-PD1 armored CD19 CAR-T cells after lymphocyte depletion by fludarabine and cyclophosphamide.

Primary Outcome Measure

Incidence of dose-limiting toxicity (DLT) [ Time Frame: 1 month after injection ]

Central Contacts

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